WO2006125692A1

WO2006125692A1 - A dosing operation in a medical device

Info

Publication number: WO2006125692A1
Application number: PCT/EP2006/061366
Authority: WO
Inventors: Louise Charlotte Klok; Jan L. Petersen; Henrik Groth Ludvigsen
Original assignee: Novo Nordisk A/S
Priority date: 2005-05-26
Filing date: 2006-04-06
Publication date: 2006-11-30

Abstract

This invention relates to a device (1) for delivery of a medicament, said device comprising: presenting means (8) , input means (6, 7) , medicament supplying means (9) and actuator means, and control means (230) that is interfaced with said presenting means, input, medicament supplying and actuator means, said control means is adapted to: receive information from said medicament supplying means about a first dose of a medicament to be supplied and generate an output signal to said actuator means resulting in the supply of said first dose in response to said received information, receive information from said input means about setting of a second dose of medicament intended to be supplied, measure a period of time starting from the point of time when said first dose of the medicament was supplied until the point of time when information is received about the setting of said intended second dose of medicament, and provide information about a warning indicating a 'double dose attempt' to said presenting means, if said measured period of time is below or equal to a predetermined period of time.

Description

A dosing operation in a medical device

The present invention relates to a device for delivery of a medicament.

In the art various devices are known to provide a diabetic patient aiding in treatment of diabetes, e.g. EP 0980 688 which discloses a method for controlling an operation of an automatic insulin syringe device, which involves a preliminary step of allowing access to a doctor mode by an authorized doctor and allowing the authorized doctor to set an upper limit of the quantity of insulin to be dispensed to a patient using the syringe device, a mode selection step of determining whether or not an operation mode of the syringe device other than the doctor mode is selected after the upper limit has been set in the preliminary step or when no doctor mode is selected, and a mode execution step of executing the operation mode selected at the mode selection step while allowing an adjustment of the quantity of insulin to be dispensed under the condition in which the upper limit is preferentially selected as a setting value in the adjustment. Selection of the doctor mode may be recognized in response to a simultaneous selection of optional ones among the switches conventionally equipped in the syringe device. Since the upper limit of the insulin quantity set in the doctor mode is preferential to a value set in a setting mode in accordance with the present invention, it is possible to eliminate harmful effects resulting from an excessive injection of insulin when insulin pumps are used.

In WO0124690, a system is provided for the delivery of medicament comprising a medicament container; a dispensing mechanism for dispensing medicament from the medicament container; an electronic data management system; and a communicator for wireless communication with a network computer system to enable communication of data between the network computer system and the electronic data management system. The electronic data management system comprises a memory for storage of data; a microprocessor for performing operations on the data; and a transmitter for transmitting a signal relating to the data or the outcome of an operation on the data.

Typically, such a system and device (e.g. a doser, a syringe with or without computer control and display functions) is being used to provide the user with a medicament.

When the user is a diabetic patient, insulin is needed from time to time to keep the patient within his treatment regiment, e.g. within certain blood glucose limits. To follow the regiment the user typically obtains information about his glucose levels from time to time in order to, subsequently, to be able to estimate when, in which concentration and in which amount insulin is to be supplied.

When a medicament is to be supplied, it is important for the user that it supplied in the in- tended dose.

If the medicament by accident is supplied in too often (e.g. the patient forgot he administered a dose recently and therefore administered a further dose), i.e. likely a too amount of the dose as compared to amount of the intended dose, this could have the reverse of the in- tended effect, i.e. the patient is not cured but faces an even worse condition due to excessive medication. For example, if e.g. insulin as the medicament by accident is supplied twice or too often as compared to the intended dose the patient subsequently experiences a too low blood sugar level, i.e. in a so called hypoglycaemia.

In the case that a too high dose of insulin is administered this will lead to - without the diabetic person necessarily is aware of it - that the intended dose of medication is not administered, which as a consequence means that a prescribed treatment with insulin is not followed properly, consequently the patient in the long run may face a severe condition.

Thus there is a need for a device with a control and supervision of the dosing mechanism to ensure that a dose is not supplied twice or too frequently. The need is fulfilled by a device for delivery of a medicament, said device comprising:

presenting means,

input means, medicament supplying means and actuator means, and

control means that is interfaced with said presenting means, input, medicament supplying (9) and actuator means,

said control means is adapted to:

receive information from said medicament supplying means about a first dose of a medicament to be supplied and generate an output signal to said actuator means resulting in the supply of said first dose in response to said received information, receive information from said input means about setting of a second dose of medicament intended to be supplied,

measure a period of time starting from the point of time when said first dose of the medicament was supplied until the point of time when information is received about the setting of said intended second dose of medicament, and

provide information about a warning indicating a "double dose attempt" to said presenting means, if said measured period of time is below or equal to a predetermined period of time.

Hereby said device can control and supervise (i.e. measure the period of time, give a warning, etc.) the dosing mechanism, thereby ensuring that the dose is neither supplied twice nor too frequently.

In an embodiment of the invention, said device further comprises accepting and optionally rejecting means, each of which is interfaced with said control means and where said control means is adapted to:

receive information from said accepting means indicating that said accepting means is operated in a response to said provided information about the warning, and generate an output signal to said actuator means resulting in the supply of said second dose, when said accepting means and the medicament supplying means subsequently are operated, and

optionally receive information from said rejecting means indicating that said rejecting means is operated in a response to said provided information about the warning, or receive no information within a specified duration of time, whereby in both cases no output signal to said actuator means is generated.

Thus it is an advantage of the invention that the user now has two choices. The first choice is that the user can chose - upon receiving the warning indicating "the double dose attempt" - to accept (through means of accepting means) to have the second dose provided to him. This could be the case when the user intentionally decides to divide a dose in e.g. two halves and have these supplied within said predetermined period of time. The second choice is that the user can chose not to have the second dose provided to him. This can be done through means of operation of said rejecting means or by means of doing nothing. Thus in this second choice the user received the warning about the "the double dose attempt" and as a response decided not to have the second dose supplied that early. Most likely, the patient now remembered that he recently administered the (first) dose and therefore does not need to administer a further, second dose at that moment of time. The medicament thus is supplied in the intended dose, i.e. said first dose of the medicament. It is thus an advantage of the invention that the device thereby also reminds the user that he recently administered a dose, namely the first dose of the medicament, consequently he seri- ously would not consider to administer another dose, namely the second dose of the medicament, since it likely is not proper to do so.

In an embodiment of the invention, said presenting means is a display, e.g. an OLED display, for displaying graphics, text and /or combinations thereof, a light (LED or bulb) or a sound emitting unit, e.g. a loudspeaker, piezoelectric sounder or buzzer, and/or a vibrator. By means of or on presenting means the user is warned and/or alerted about his/her "double dosing" attempt. Said loudspeaker, piezoelectric sounder, and/or vibrator provide(s) for that a visually disabled person also can receive the warning or alert. Furthermore, the vibrator provides that a deaf person can be warned.

Typically the predetermined time can be determined by the user of said device.

In an embodiment of the invention, said predetermined period of time is selected as a fixed number from about 0 minutes to about 4 hours.

In an embodiment of the invention, said predetermined period of time is selected to about two hours.

In an embodiment of the invention, said predetermined period of time is selected to about one hour.

In an embodiment of the invention, said predetermined period of time is selected to about fifteen minutes. In an embodiment of the invention, said input means comprises dose setting means, a keyboard or a remote command all of which each indicates a dose setting of said medicament,

Furthermore, said input means comprises a dosing button means.

In an embodiment of the invention, said medicament is a solution of a polypeptide, preferably insulin, GLP-1 or human growth hormone, most preferably insulin.

As discussed, the invention may be carried out on a device, e.g. a medical device. In the present context, the term 'medical device' can mean an injector type device (such as a pen injector or a jet injector) for delivering a discrete dose of a liquid medication (possibly in the form of small drops), a medication pump for continuous delivery of a liquid medication, an inhaler, spray or the like for delivering a discrete or continuous dose of a medication in vaporized, 'atomized' or pulverized form, preferably the medication is insulin. The medical device can also mean a blood glucose tester or a BGM (blood glucose measurement device), e.g. a device using so-called test-strips for the manual measurement of the glucose level in the blood or a more advanced device, i.e. a CGM (continuous glucose measurement device) performing automatic continuous measurements of the blood glucose level. In the latter case, the medical device devices also comprise means for the supply of the medication to the pa- tient.

US6540672, US6656114, US2002010432 and US2003032868 all disclose medical devices, which are hereby incorporated by reference in its entirety. US patent 5888477 which is hereby incorporated by reference in its entirety) discloses an inhaler with robust features that may be used for insulin delivery. US patent 5785049 to Smith et al (which is hereby incorporated by reference in its entirety) discloses a device suitable for powdered medication delivery.

The invention will be explained more fully below in connection with preferred embodiments and with reference to the drawings, in which:

fig. 1 shows an exemplary embodiment of a device, fig. 2 shows an exemplary embodiment of the devices' electronic circuit, and fig. 3 shows a flowchart of the invention. Throughout the drawings, the same reference numerals indicate similar or corresponding features, functions, etc.

Figure 1 discloses an exemplary embodiment of the device 1 , e.g. a medical device having housing. An injection needle 2 is connected to a needle assembly 3 connected to the distal end of the housing and communicates with a container or reservoir 4, e.g. a cartridge or ampoule containing the medicine to be administered, e.g. an amount of basal or bolus insulin.

As an integral part of the device, a piston is provided at the end of a piston rod, which - in an embodiment of the invention - can be moved forth within the cylindrical shaped container 4, e.g. a Penfill ® cartridge. The force for movement could be provided by a motor, e.g. a DC motor, a stepper motor, or an AC motor as well. When the piston is moved in the direction towards the injection needle the medicine to be administered can be expelled through said injection needle. The movement can be controlled by control means.

Input means, e.g. a plurality of operating buttons in an exemplary embodiment of the medical device is provided, these comprise e.g. a dose setting button 5 for setting a dose to be injected, an accept button 6 for accepting the dialled dose, medicament supplying means e.g. an injection button 9 and an ESC (escape) button 7 for moving backwards in the menu and/or to reject a dosing attempt, the ESC button is an example of operable rejecting means applicable to reject the dosing attempt, i.e. to instruct control means that this dose is not to be provided.

Additionally or alternatively, said input means could comprises a remote command, e.g. send from an external device, which command indicates a dose, e.g. a dose setting, of said medicament.

In case the device is an inhaler, said medicament supplying means is e.g. a button instructing the inhaler to release the medicament. Correspondingly, in case the device is a spray, said medicament supplying means is e.g. a button instructing the spray to provide the medicament.

Alternatively or additionally, input means could be a keyboard or mouse integral or attached to the device or a remote command, e.g. the remote command indicating the set dose and an attempt to inject the dose. Alternatively or additionally, input means could be implemented by means of soft keys on a display, the operation of such a soft key could be a touch on an icon and / or on a textual presentation.

In order to perform an injection the user could dial the size of the dose to be injected using the dial up/dial down button 5. As the dose is dialled, the size of the dose is displayed on presenting means, e.g. in the display 8.

Said presenting means could be implemented by means of an OLED display, which however introduces a potential safety issues: Varying environmental light conditions causes varying display reading quality thus introducing the possibility of misinforming the user. This could be avoided when the device further comprises a light sensor, which is placed near the OLED display in order to measure the incident light. Control means, e.g. an electronic circuit, microcontroller measures the signal from the light sensor and subsequently determines the intensity of the emitted OLED light. Hereby, adjustment of the emitted OLED light intensity is pos- sible, which increases readability and reduces the possibility of the user not reading the right content, e.g. the size of the dose to be injected using, from the OLED display.

When the set dose is dialled to an adequate size, the user operates accepting means, e.g. the accept button 7 or key thereby confirming that the set dose is to be provided. After having inserted the injection needle 2 into a tissue of a diabetic patient, the user operates medicament supplying means e.g. the injection button 9 to release the set dose.

The device further comprises actuator means, i.e. means by means of which a dose of a medicament can be delivered out of the device, e.g. through said injection needle. As an ex- ample, when the user operates medicament supplying means, e.g. the injection button 9, to release the set dose and this is accepted by the control means of the device, the operation of providing the dose is performed by means of said actuator means. The actuator means can be controlled control means, which e.g. is a microprocessor, an ASIC, etc and/or a fast wired logic circuitry; from said control means an output signal in an analogue or digital form is pro- vided to said actuator means.

However, according to the invention the actuator means is only controlled and powered if allowed by the device, e.g. if a sufficient long period of time has passed since the previous dose was given or an accept to deliver the medicament intended (e.g. by means of the ac- cept button 7) was received. The device furthermore can be equipped with a cap, which can be in an off and an on state. Said device further can be equipped with a detachable needle for injection, which needle during the operation of the device frequently is to be changed. In the device the medicament, e.g. insulin typically is supplied in an exchangeable container, e.g. a Penfill ®. For the latter it is typically stored in a compartment of the device and typically there is a lid or a cover to the compartment, which lid can be in a closed or an open state. For the cap and the needle, respectively there is a need to sense their presence or not. Correspondingly, for the compartment cover/lid there is a need to sense whether it is on or off, e.g. open or closed. The sens- ing in all cases can be performed by means of a Hall switch in conjunction with a magnet. This gives a safe, reliable, closeness avoiding that dust and/or liquid enter(s) the switch contact. By using a magnet to generate a high magnetic field to the Hall element, a very safety state is generated, when the hall element in its active state

The device furthermore can be equipped with a piston rod, which - when moved - can be used to supply a medicament from said container. The piston rod can be automatically triggered to move when dismounting and mounting the cartridge compartment. This could be done by one or two hall element(s) registering when the cartridge compartment is opened and closed and sending the signal to the control means - possibly including a motor control- ler - which controls the motor to run, stop and reverse. When opening/dismounting the cartridge compartment, the piston rod is then controlled to move backwards making it possible to mount a new cartridge. The opening/dismounting of the cartridge compartment can be sensed by said control means to which Hall switches in conjunction with corresponding magnets are connected. In general, the Hall switch in conjunction with a corresponding magnet exhibits a hysteresis curve between the on and off state and vice versa, consequently the Hall switch is very immune towards noise, electromagnet and electric fields, whereby it is a very reliable sensor.

In general, for any element of said device, which can be in an open, closed, on or off state, or in a state of presence or absence, it is therefore advantageous to apply a Hall switch in con- junction with a corresponding magnet as the sensor to sense the state of said element.

Figure 2 discloses an exemplary embodiment of the devices' electronic circuit. Said device can be a medical device. This display of data can be implemented in a method which can be run on any general purpose device / computer system as shown in the figure, which shows its internal structure. The computer system (210), e.g. a device consists of various subsys- terns interconnected with the help of a system bus (220). The control means, e.g. microprocessor (230) or CPU communicates and controls the functioning of other subsystems. Memory (240) helps the microprocessor in its functioning by storing instructions and data, e.g. such as medication of bolus insulin, by knowledge of the amount of insulin to be injected, how long time has passed since the last dose actually was supplied by means of said actuator means. Said actuator means may be implemented by means of one or more transistors, e.g. a Darlington coupling, by means of solenoid controlled valve, an h-bridge of four transistors controlling the movement of said piston rod. As an example, when said actuator means is powered, the force for a pistons movement could be provided by said motor kinds. In gen- eral, when actuator means is provided with an output signal, i.e. sufficient controlled and powered, e.g. by means of said control means in response to medicament supplying means, e.g. injection button, said dose then is allowed to be provided.

Fixed Drive (250) may be used to hold these data, e.g. in a database structure and instructions permanent in nature like the operating system and other programs, furthermore the fixed drive may contain data for a subsequent display. Display adapter (260) is used as an interface between the system bus and the display device (8), which is generally a monitor or a display. In other words, the display is interfaced with said processor, where the processor can be configured to cause the display to display various data as graphics, numbers text and any combinations thereof. This monitor or display can be used to display various data, e.g. medication of bolus insulin performed, to be performed from a treatment regimen at various point of time and / or a warning regarding "a double dose attempt". The processor as an example of control means could be adapted to supervise the time between an actual dose performed until a next dosing attempt is made. If said control means detects that the dosing attempt is executed, e.g. a dose is being set by means of the dose setting button for setting a dose to be injected, before a certain time has passed since the previous dose actually was supplied, the control means could provide a warning indicating "a double dose attempt", this could be done by means of presenting means, e.g. the display device, by means of a light, e.g. through a LED or a bulb, and /or by means of a sound emitted by means of a loud speaker, buzzer or a piezoelectric sounder having a low power consumption. Alternatively or additionally, said presenting means could be a vibrator vibrating the device when the warning is to be provided.

The warning indicating "a double dose attempt" is given to a light emitting unit, e.g. the LED and/or the bulb, a sound emitting unit, e.g. the loud speaker and/or the buzzer and/or the vibrator. Each of these units and the vibrator are connected and controlled by said control means.

Following the determination of "a double dose attempt" said control means is adapted to allow and execute this dosing attempt in case an accept button or a soft-key having the same functionality is operated, e.g. pressed. Conversely, in case an ESC (Escape) button or a soft- key having the similar functionality is operated, this dosing attempt is ignored, i.e. no dose is provided, e.g. expelled, injected or released by means of said actuator means. Alternatively, if the device receives no information within a specified duration of time (following the "double dose attempt") also no output signal is generated to said actuator means. Said duration of time could be specified to be fifteen seconds, thirteen seconds or one, two or three minutes, etc during a setup or initialization of the device.

In case said control means detects that the next dosing attempt is executed after a certain time has passed after an actual former administration was provided to the patient, the control means could allow that this particular next dose is subsequently expelled by means of said actuator means.

The network interface (280) may be used to connect the computer with other com- puters on a network through wired or wireless means. These devices on the network can also be medical devices. These medical devices can be capable of storing patient related data such as drug dosage, point of times for drug dosage, e.g. for bolus insulin. These devices communicate with the computing device using various communication mediums. The communication means can be wired or wireless such as cable, RS232, Bluetooth, infrared etc using various communication protocols such as TCP/IP, SSL etc. The computer system might also contain a sound card (290). The system may be connected to various input devices like keyboard (292) and mouse (294) and output devices like printer (296). Various configurations of these subsystems are possible. It should also be noted that a device or system implementing the present invention might use less or more number of the subsystems than described above.

The number of devices can be expanded and customized as per the need to establish an efficient patient-doctor-relative-peer network. For example the computing system may periodically logon to a Local Area Network, or Internet to transmit the user readings, e.g. what doses of bolus insulin was administered at which point of times on a remote database server that might be used to generate reports or receive a treatment regimen for the diabetic patient from a different computing system such as that of a doctor, relative of the patient and the like. These computing devices can be general-purpose desktops or other variations such as laptop, cell phones, Personal Digital Assistants (PDAs), blood glucose meters, etc.

In an embodiment of the device, the device further comprises a temperature sensor and some software implemented in the control means, which can sense if the device is subjected to a too high or too low temperature for a certain period of time and, accordingly the device can notify the user for example by means of presenting means, e.g. if an insulin cartridge has been inserted the insulin might be damaged due to a wrong storage temperature. The temperature sensor can also sense whether a very warm or cold cartridge is inserted in the device is within a normal temperature range- which e.g. could be set up on the device - and notify the user that the insulin inserted might already be damaged.

Accordingly, the user will be notified of potential ineffective insulin and can make the appropriate corrective actions, e.g. throw the old cartridge away and be provided with a fresh cartridge.

Hereby it is avoided, that if the insulin is subjected to a high temperature (higher than X de- grees, where X is specified for the specific insulin type) or a low temperature (lower than Y degrees, where Y is specified for the specific insulin type) in a certain period of time (also specified for the specific insulin type) that the insulin degenerates and becomes ineffective, consequently, harm to the patient is avoided.

In an embodiment of the invention, the device is equipped with an electronic diary - implemented by means of and controlled by said control means - which diary is applied to register all the insulin medications and blood glucose measurements the diabetic patient performs and, accordingly these can be presented on said presentation means, preferably on said display. The blood glucose levels measured and frequency and doses of insulin medication might vary unusually if the diabetic patient is sick, stressed, pregnant, eating a lot, is at a party, and/or is doing sports.

The unusually blood glucose measurements and insulin intake are shown in the diary as normal actions. If the diabetic patient forgets why a certain blood glucose measurement or insulin intake is varying unusually, he/she might do corrective actions to the treatment based on wrong conclusions. Or the doctor might advice wrongly.

In the inputs to the diary, it is therefore possible to mark, e.g. as a property to the blood glu- cose and insulin actions registered in the diary with notes saying e.g. "sick", "stressed", "pregnant", "party", "sports", etc. The notes might be predefined or can be written as the diabetic patient chooses. By marking the actions in the diary it is possible for the diabetic patient and/or the doctor to see why a certain action (medication and/ or a blood glucose measurement) differs from what would be expected in a more normal day, i.e. where no influence from sickness, stress, pregnancy, party or sport activities, etc is the case. Hereby, it is avoided that unusually blood glucose measurements and insulin intake are shown wrongly in the diary as normal actions. Further, the situation is avoided when the diabetic patient forgets why a certain blood glucose measurement or why a medication of insulin is varying unusually, he/she might do corrective actions to the treatment based on wrong conclusions. Ac- cordingly, it is avoided that the doctor advices are based on wrong interpretation of data. The diary can remind (by means of said mark, note or property) the diabetic patient and/or the doctor of why certain actions differ from expected actions.

In an embodiment of the invention, the device software implementing the diary allows the diabetic patient to mark an insulin medication, e.g. an injection as a "not treatment relevant".

The communication to enter this note and/or property is done by means of e.g. a display and one or more keys on the device. When a medication of insulin is marked, e.g. a note and/or as a property, as "not treatment relevant", the device leaves out this medication event from the diary, and, accordingly this medication event is excluded from subsequent computations, e.g. statistics. It is hereby avoided that not relevant actions are included in the diary, e.g. sometimes it may not be relevant to include an injection in the various statistics the device can provide, e.g. if the diabetic patient has made an injection into the air. He/she may not want this injection to be visible in a diary or be part of a statistic over view of the medications, e.g. injections or infusions. Accordingly, it is avoided that a subsequent doctor advice - using the diary - is based on non relevant data.

In an embodiment of the device, the user can choose between various profiles, e.g. three user profiles: "Simple", "Basic" and "Advanced". These profiles could be displayed on the presenting means. In the main menu on the device the user can choose to enter a user profiles submenu. Here the user can choose between different user profiles, which represent different configurations of the device functions, e.g. three profiles can be chosen:

The "simple" user profile might just contain the functions:

Priming, i.e. air shot to avoid providing air in the medicament Dialing dose

Accepting dialed dose, e.g. the OK button, Dosing, e.g. by means of the medicament supplying means - Check of time and size of last provide dose of the medicament

Setting clock and date Setting a fixed dose

The "basic" user profile might contain the above mentioned functions plus: - Diary: checking time and date of the last e.g. 30 provided medications

Action cards: Checking the last e.g. 50 actions done on the device (actions like priming, dosing, setting clock, setting reminder etc.)

Setting a reminder to remind user to take insulin on a specific date and time Setting a max dose

The "advanced" profile might contain the above mentioned functions in the "simple" and "basic" profiles plus:

Synchronizing with BG, i.e. a Blood Glucose meter, e.g. for transfer of blood glucose data - Manually enter a blood glucose measurement

Graphical representation of e.g. the last 3 months provided medications and blood glucose measurements

Average Dose size of the e.g. 30 provided medications Average blood glucose level of the, e.g. last 30 glucose measurements - Add to diary: Manually adding if the user has been exercising, been ill, etc.

Entering of a CIR, i.e. Carbohydrate to Insulin Ratio and/or an ISF, i.e. Insulin Sensitivity Factor, for a subsequent calculation of a proposed dose of a medication with insulin.

The number 30 could be any other number, e.g. 5, 10, 20, 40, 50, 100, 200, etc, which could be a setup and/or an initialization of the device. The "simple" user profile might be chosen by people who are just recently diagnosed with diabetes and have to provide themselves with a medicament for the first time. They just need to be able to dial a dose and inject it and they need to be able to check the size and time of their last medication action. These are the fundamental functions a new diabetic might need. Of course then he/she then might need to be able to set the time and date in order to be able to use the other functions. When having less functionality when starting up on the treatment, the patient or user can concentrate on the fundamentals about learning how to cope with diabetes and how in which amount to provide insulin. This means the user will not get con- fused about all the other possibilities there are when treating diabetes and he/she will not accidentally do something wrong on that account.

Also people who do not pay so much attention to their disease but "just" want to provide the medicament, e.g. insulin can choose the simple profile. This way they get a simple user inter- face without the unnecessary functions.

The "basic" user profile might be for the experienced diabetic, who is interested in his/her medical compliance. The user wants to take responsibility for their disease and treatment. This user sets the device on basic user profile and gets the additional functionalities corre- sponding to his/her needs.

The "advanced" user profile is for experienced diabetics, who want to monitor their treatment closely. This user chooses the advanced profile and gets all the devices functionality.

It is hereby an advantage that the device can have many functions but it is easy to understand and use due to the hierarchy of profiles. By implementing different user profiles the device can appear as simple or as complex as the user can handle. One profile might contain only the most basic and simplest functions. Another profile might contain additional functionality suited for more skilled users. Another profile might contain full device functionality which is suited for the advanced and experienced users.

The device can contain as many profiles as needed. If a user is not competent to use certain device functions the device can be set to a profile which does not contain those functions. Moreover, it is a further advantage that the user will not get confused by the many device functions.

If a user doesn't need to operate all the device functions in his/her daily medical treatment a simpler device setup can be easier and quicker to use. This prevents the user from using functions he/she is not skilled to use. Subsequently, maltreatment can be avoided.

Figure 3 shows a flowchart of the invention. The flowchart describing an exemplary embodiment of a method implementation of the invention which could be implemented by the means of the device as discussed in the foregoing figures, e.g. control means controls the flowchart implementation, e.g. by means of an executable program code, and all of said means are used as inputs to and outputs from said control means.

In step 100, the control means can receive information from said input means about a first dose of a medicament to be supplied, e.g. the medicament supplying means is operated, and as a response the control means generates an output signal to said actuator means. As a result, the supply of said first dose is provided by means of said actuator means.

In step 110, the control means can receive information from said input means about an attempt to set a second dose of medicament, thus the user here attempts (intends) to supply a second dose after a first dose was provided to him in step 100. As an example, a second dose (amount of medication, e.g. in IU) is being set by means of the dose setting button, thus the user attempts to set the second dose, which is indented to be supplied.

In step 120, the control means measures a period of time starting from the point of time when said first dose of the medicament was supplied (in step 100) until the point of time when information is received about said setting of an intended second dose of medicament, i.e. the attempt in step 110.

In step 130, the control means checks whether said measured period of time is below or equal to a predetermined period of time, in these cases the control means provides information about a warning indicating a "double dose attempt" to said presenting means, hereafter or concurrently the method proceeds in either step 140 or 150 depending on which of rejecting means or accepting means that is operated in response to the warning. Conversely, i.e. the measured period of time is higher than the predetermined period of time, i.e. no "double dose attempt" then the method proceeds to step 160, i.e. where said intended second dose of medicament is allowed to be provided - provided the medicament supplying means subsequently is operated.

Said predetermined period of time can be determined, e.g. setup or keyed, by a user of said device, or it could be selected as a fixed number from about 0 minutes to about 4 hours, to about two hours, to about one hour or to about fifteen minutes, or to any other duration of time, whichever the user of the device prefers.

In step 140, accepting means, e.g. an OK or accept button or a corresponding soft-key is op- erated. The user here noted the "double dose attempt" warning presented to him, but even though he has this information he decides (e.g. by means of accepting means) to let the dose be provided to him. As a result the method proceeds to step 160.

In step 150, rejecting means is operated, e.g. the ESC button or the corresponding soft-key is operated. As a result the method is not allowed to proceed to step 160. As a consequence, said intended second dose of medicament will not be allowed to be provided. The user here experienced the "double dose attempt" warning and consequently decides (e.g. by means of the ESC button) not to let the dose be provided.

In step 160, said intended second dose of medicament can be provided. It could be the result of that the accepting means in step 140 was operated. In that case the device control means here receives information from said accepting means indicating that said accepting means is operated, subsequently the medicament supplying means (e.g. the injection key) needs to be operated before said control means generates an output signal to said actuator means, which results in the supply of said second dose. The user here experienced the "double dose attempt" warning and consequently decided to let the dose be provided to him (by means of the accept key and by the subsequent pressing of the injection key). A reason for doing so could be that the user knowingly decided to let the dose be provided in two halves - each half being said intended second dose of medicament - within a time period shorter than said predetermined period of time.

This step 160 is also allowed to be executed by the control means since the measured period of time was higher than the predetermined period of time in step 130, thus no attempt was performed to dose a medicament too frequently, and, consequently the dose is allowed to be provided by the subsequent operation of the medicament supplying means. When the method has completed its task, it loops back to step 100 again. When the second dose actually was provided, this action replaces the notation of "first dose" action in this starting step, etc.

In an embodiment of the invention, it is possible on the device to setup a max dose which cannot be exceeded when dialling the dose. The function can be software controlled or mechanically controlled. Hereby, it can be avoided to dial a dose which is too large by mistake, e.g. by persons who are not skilled to dial the right dose size, or not skilled to operate the device, or by misreading of scale by accident or if the person is visually impaired. If a person shall never have a dose larger than X the max dose can be set to X preventing a large over dose. This might prevent hypoglycaemia. Or the max dose can simply be set to the personal limit of hypoglycaemia. If the person needs more insulin than the set max dose, he/she must perform multiple injections. But it prevents hypoglycaemia by dialling a too large dose by mistake. This might be especially important with children.

Conversely, the max dose function can be set to off in a setup menu or mechanically (e.g. by controlling a split pin) and then the dose can be dialled as normal.

In an embodiment of the invention, it is possible to set a fixed dose which cannot be changed. The function can be software controlled or mechanically controlled. The fixed dose might be shown in the device display before each injection. When the fixed dose is set, it is not possible to change it.

Hereby, it can be avoided to dial a dose which is too small or too large by mistake e.g. by persons who are not skilled to dial the right dose size, or not skilled to operate the device, or by misreading of scale by accident or if visually impaired, or because user has forgotten the correct dose size ordered by the doctor.

The method is incorporated in the aforementioned computing devices as by instructions in the software that are carried out by the computer system. Again, the software may be implemented as one or more modules for implementing the method.

In particular, the software may be stored in a computer readable medium, including the storage device or that is downloaded from a remote location via the interface and communica- tions channel from the Internet or another network location or site. The computer system in- eludes the computer readable medium having such software or program code recorded such that instructions of the software or the program code can be carried out. The use of the computer system preferably affects advantageous apparatuses for constructing a runtime symbol table for a computer program in accordance with the embodiments of the invention. Said wireless transfer of data may be performed by means of transmission means, a network, e.g. a local area network (LAN), a wide area network (WAN), or any combination thereof, e.g. the Internet, an intranet, an extranet, or an on-line service.

Alternatively, the wireless transfer of data may be performed by means of IrDA, a Bluetooth communications standard or any other way as known in the art to transfer data wirelessly between two devices, e.g. a wireless client adapter, a wireless LAN adapter, etc. The wireless transfer may be implemented following a medical communication standard such as MICS, Medical Implant Communications Services or WMTS, i.e. the Wireless Medical Telemetry Service. Further, the transfer of data may be performed by means of a wireless LAN such as WI-FI using various standards such as 802.11a, 802.11b or 802.11g or future devel- opments thereof, e.g. Wimax, UWB (Ultra Wide Band) or ZigBee as a dynamic network implementation. E.g. said wireless transfer of data could be a remote command indicating a dose setting (e.g. for the first and second dose) of said medicament, which remote command can be received by said device.

A computer readable storage medium may be a magnetic tape, an optical disc, a digital video disk (DVD), a compact disc (CD or CD-ROM), a mini-disc, a hard disk, a floppy disk, a smart card, a PCMCIA card, a ram stick, etc. or any other kind of media that provides a computer system with information regarding how instructions/commands should be executed.

Any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context.

Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. Unless otherwise stated, all exact values provided herein are representative of corresponding approximate values (e.g., all exact exemplary values provided with respect to a particular factor or measurement can be considered to also provide a corresponding approximate measurement, modified by "about," where appropriate).

All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.

The description herein of any aspect or embodiment of the invention using terms such as "comprising", "having," "including," or "containing" with reference to an element or elements is intended to provide support for a similar aspect or embodiment of the invention that "consists of, "consists essentially of, or "substantially comprises" that particular element or elements, unless otherwise stated or clearly contradicted by context (e.g., a composition described herein as comprising a particular element should be understood as also describing a composition consisting of that element, unless otherwise stated or clearly contradicted by context).

This invention includes all modifications and equivalents of the subject matter recited in the aspects presented herein to the maximum extent permitted by applicable law.

All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference in their entirety and to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein (to the maximum extent permitted by law).

All headings and sub-headings are used herein for convenience only and should not be construed as limiting the invention in any way.

The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

The citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity, patentability, and/or enforceability of such patent documents.

Claims

1. A device (1) for delivery of a medicament, said device comprising:

presenting means (8),

input (5, 6, 7) means, medicament supplying means (9) and actuator means, and

control means (230) that is interfaced with said presenting means (8), input (5, 6, 7), medicament supplying (9) and actuator means,

said control means (230) is adapted to:

receive information from said medicament supplying means (9) about a first dose of a medicament to be supplied and generate an output signal to said actuator means resulting in the supply of said first dose in response to said received information,

receive information from said input means (5, 6, 7) about setting of a second dose of medicament intended to be supplied,

provide information about a warning indicating a "double dose attempt" to said presenting means (8), if said measured period of time is below or equal to a predetermined period of time.

2. A device according to claim 1 , wherein the device further comprises accepting (6) and optionally rejecting means (7), each of which is interfaced with said control means and where said control means (230) is adapted to:

receive information from said accepting means (6) indicating that said accepting means is operated in a response to said provided information about the warning, and generate an out- put signal to said actuator means resulting in the supply of said second dose, when said accepting means (6) and the medicament supplying means (9) subsequently are operated, and

optionally receive information from said rejecting means (7) indicating that said rejecting means is operated in a response to said provided information about the warning, or receive no information within a specified duration of time, whereby in both cases no output signal to said actuator means is generated.

3. A device according to any of the preceding claims, wherein said presenting means is a display (8), e.g. an OLED display, for displaying graphics, text and /or combinations thereof, a light (LED or bulb) or a sound emitting unit, e.g. a loudspeaker, piezoelectric sounder or buzzer, and/or a vibrator.

4. A device according to any of the preceding claims, wherein said predetermined period of time can be determined by a user of said device.

5. A device according to any of the preceding claims, wherein said predetermined period of time is selected as a fixed number from about 0 minutes to about 4 hours.

6. A device according to any of the preceding claims, wherein said predetermined period of time is selected to about two hours.

7. A device according to any of the preceding claims, wherein said predetermined period of time is selected to about one hour.

8. A device according to any of the preceding claims, wherein said predetermined period of time is selected to about fifteen minutes.

9. A device according to any of the preceding claims, wherein said input means com- prises dose setting means, a keyboard or a remote command indicating a dose setting of said medicament, and a dosing button means.

10. A device according to any of the preceding claims, wherein said medicament is a solution of a polypeptide, preferably insulin, GLP-1 or human growth hormone, most preferably insulin.